Inguinal HerniaPREPARENCT04074200
Pain and Quality of Life After Inguinal Hernia Repair
An observational study of Inguinal Hernia, run by Intuitive Surgical at 1 site in United States.
Trial summary
This study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Open Inguinal Hernia Repair, Laparoscopic Inguinal Hernia Repair and Robotic-Assisted Inguinal Hernia Repair
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2019to 6 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo an elective hernia repair procedure and meet all eligibility criteria will be considered for enrollment.
Who may be able to join
- Subject is between 18 and 80 years of age.
- Subject is a candidate for an elective primary inguinal hernia repair.
Who cannot join
- Subject receiving a bilateral open repair.
- Subject who will have an emergent hernia repair.
- Subject with a history of chronic pain and/or taking daily pain medications for >6 weeks.
- Subject with a history of substance abuse and/or current (within 30 days) narcotic use.
- Subject with a history of methicillin-resistant Staphylococcus aureus (MRSA) infection.
- Diabetic subjects requiring insulin.
Show all 17Show fewer
- Subject with recurrent hernias.
- Subject who will require the use of Exparel during the surgical procedure.
- Subject who will undergo a concomitant hernia repair or any other concomitant procedure.
- Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery.
- Subject is contraindicated for surgery.
- Subject has a known bleeding or clotting disorder.
- Pregnant or suspect pregnancy.
- Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent.
- Subject belonging to other vulnerable population, e.g, prisoner or ward of the state.
- Subject unable to comply with the follow-up visit schedule.
- Subject is currently participating in another research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: PREPARE: A PRospective Evaluation of Pain After Inguinal Hernia REpair
This study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted inguinal hernia repair.
Read the detailed description
This is a prospective, multi-center, observational pilot study comparing outcomes of pain and quality of life after inguinal hernia repair between open, laparoscopic, and robotic-assisted surgical approaches. The study will focus on short-term outcomes through 3 months post-operation. During the post-operative period through 3 months, pain medication intake, pill count, subject-reported pain (on post-operative days 1-3 and 14 days post-surgery), and quality of life (at 14 days, 30 days, and 3 months post-surgery), incidence of intra- and post-operative complications, and time to return to normal activity will be collected.
- Conditions
- Inguinal Hernia
- Being tested
- Open Inguinal Hernia Repair, Laparoscopic Inguinal Hernia Repair, Robotic-Assisted Inguinal Hernia Repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Inguinal Hernia RepairProcedure or surgery
With the patient under anesthesia, a single incision is made in the groin area. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific open approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC.
Laparoscopic Inguinal Hernia RepairProcedure or surgery
With the patient under general anesthesia, several small incisions are made in the groin area. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope (a lighted scope used to visualize the hernia) are inserted to complete the repair. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific laparoscopic approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC.
Robotic-Assisted Inguinal Hernia RepairDevice
With the patient under general anesthesia, several small incisions are made in the groin area. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the patient and used to complete the procedure. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific robotic-assisted approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC.
| Study group | Role | What they receive |
|---|---|---|
| Open Inguinal Hernia Repair | These subjects will undergo an inguinal hernia repair using an open surgical approach. Receives: Procedure: Open Inguinal Hernia Repair | |
| Laparoscopic Inguinal Hernia Repair | These subjects will undergo an inguinal hernia repair using a laparoscopic surgical approach. Receives: Procedure: Laparoscopic Inguinal Hernia Repair | |
| Robotic-assisted Inguinal Hernia Repair | These subjects will undergo an inguinal hernia repair using a robotic-assisted surgical approach. Receives: Device: Robotic-Assisted Inguinal Hernia Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Scores from Baseline to 14 Days
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Measured: 14 days post-surgery
Change in Pain Scores from Baseline to 1 Day
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Measured: 1 day post-surgery
Change in Pain Scores from Baseline to 2 Days
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Measured: 2 days post-surgery
Change in Pain Scores from Baseline to 3 Days
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Measured: 3 days post-surgery
Change in Narcotic Usage from 1 Day Post-Surgery to 3 Months Post-Surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
Measured: 3 months post-surgery
Change in Narcotic Usage from 1 Day Post-Surgery to 30 Days Post-Surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
Measured: 30 days post-surgery
Change in Narcotic Usage from 1 Day Post-Surgery to 14 Days Post-Surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
Measured: 14 days post-surgery
Change in Narcotic Usage from 1 Day Post-Surgery to 7 Days Post-Surgery
Narcotic usage after the inguinal hernia repair procedure as determined by patient Pain Diary completed at home
Measured: 7 days post-surgery
Secondary outcomes (11)
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 7 Days Post-Surgery
Over the counter (OTC) pain medication usage after the inguinal hernia repair procedure as determined by patient Pain Diary completed at home
Measured: 7 days post-surgery
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 3 Months Post-Surgery
Over the counter (OTC) pain medication usage after the inguinal hernia repair procedure as determined by patient reporting of OTC pain medication usage at follow-up visits
Measured: 3 months post-surgery
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 30 Days Post-Surgery
Over the counter (OTC) pain medication usage after the inguinal hernia repair procedure as determined by patient reporting of OTC pain medication usage at follow-up visits
Measured: 30 Days post-surgery
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 14 Days Post-Surgery
Over the counter (OTC) pain medication usage after the inguinal hernia repair procedure as determined by patient reporting of OTC pain medication usage at follow-up visits
Measured: 14 Days post-surgery
Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 3 Months Post-Surgery
Quality of life assessment using the EQ-5D-5L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Measured: 3 months post-surgery
Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 30 Days Post-Surgery
Quality of life assessment using the EQ-5D-5L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Measured: 30 Days post-surgery
Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 14 Days Post-Surgery
Quality of life assessment using the EQ-5D-5L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Measured: 14 Days post-surgery
Operative Time
Operative time, defined as first incision to closure of the incision
Measured: Intra-operative
Length of Hospital Stay (LOS)
How long the patient was admitted to the hospital
Measured: Admission to the hospital to discharge from the hospital (check out time), up to an approximate of one week
Conversion to Open
Incidence of conversions of the laparoscopic or robotic-assisted procedure
Measured: Intra-operative
Number of Complications
Intra-operative or post-operative complications related to the inguinal hernia repair
Measured: Intra-operative through the 3 month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start26 Aug 2019
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074200
- Sponsor's protocol ID
- ISI-IHP-2018
- Acronym
- PREPARE
- Status last verified
- Oct 2024
- First submitted
- 22 Aug 2019
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREPARE: A PRospective Evaluation of Pain After Inguinal Hernia REpair
- ClinicalTrials.gov ID
- NCT04074200
- Acronym / sponsor ID
- PREPARE / ISI-IHP-2018
- Conditions
- Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted inguinal hernia repair.
Detailed description
This is a prospective, multi-center, observational pilot study comparing outcomes of pain and quality of life after inguinal hernia repair between open, laparoscopic, and robotic-assisted surgical approaches. The study will focus on short-term outcomes through 3 months post-operation. During the post-operative period through 3 months, pain medication intake, pill count, subject-reported pain (on post-operative days 1-3 and 14 days post-surgery), and quality of life (at 14 days, 30 days, and 3 months post-surgery), incidence of intra- and post-operative complications, and time to return to normal activity will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Inguinal Hernia Repair | – | Procedure: Open Inguinal Hernia RepairThese subjects will undergo an inguinal hernia repair using an open surgical approach. |
| Laparoscopic Inguinal Hernia Repair | – | Procedure: Laparoscopic Inguinal Hernia RepairThese subjects will undergo an inguinal hernia repair using a laparoscopic surgical approach. |
| Robotic-assisted Inguinal Hernia Repair | – | Device: Robotic-Assisted Inguinal Hernia RepairThese subjects will undergo an inguinal hernia repair using a robotic-assisted surgical approach. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo an elective hernia repair procedure and meet all eligibility criteria will be considered for enrollment.
Key inclusion criteria (2 listed)
- Subject is between 18 and 80 years of age.
- Subject is a candidate for an elective primary inguinal hernia repair.
Key exclusion criteria (17 listed)
- Subject receiving a bilateral open repair.
- Subject who will have an emergent hernia repair.
- Subject with a history of chronic pain and/or taking daily pain medications for >6 weeks.
- Subject with a history of substance abuse and/or current (within 30 days) narcotic use.
- Subject with a history of methicillin-resistant Staphylococcus aureus (MRSA) infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Inguinal Hernia RepairWith the patient under anesthesia, a single incision is made in the groin area. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific open approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC. | Procedure or surgery | Open Inguinal Hernia Repair |
| Laparoscopic Inguinal Hernia RepairWith the patient under general anesthesia, several small incisions are made in the groin area. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope (a lighted scope used to visualize the hernia) are inserted to complete the repair. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific laparoscopic approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC. | Procedure or surgery | Laparoscopic Inguinal Hernia Repair |
| Robotic-Assisted Inguinal Hernia RepairWith the patient under general anesthesia, several small incisions are made in the groin area. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the patient and used to complete the procedure. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific robotic-assisted approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC. | Device | Robotic-assisted Inguinal Hernia Repair |
Primary outcome
Change in Pain Scores from Baseline to 14 Days
Time frame: 14 days post-surgery
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Change in Pain Scores from Baseline to 1 Day
Time frame: 1 day post-surgery
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Change in Pain Scores from Baseline to 2 Days
Time frame: 2 days post-surgery
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Change in Pain Scores from Baseline to 3 Days
Time frame: 3 days post-surgery
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Change in Narcotic Usage from 1 Day Post-Surgery to 3 Months Post-Surgery
Time frame: 3 months post-surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
Change in Narcotic Usage from 1 Day Post-Surgery to 30 Days Post-Surgery
Time frame: 30 days post-surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
Change in Narcotic Usage from 1 Day Post-Surgery to 14 Days Post-Surgery
Time frame: 14 days post-surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
Change in Narcotic Usage from 1 Day Post-Surgery to 7 Days Post-Surgery
Time frame: 7 days post-surgery
Narcotic usage after the inguinal hernia repair procedure as determined by patient Pain Diary completed at home
11 secondary outcomes
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 7 Days Post-Surgery
Time frame: 7 days post-surgery
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 3 Months Post-Surgery
Time frame: 3 months post-surgery
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 30 Days Post-Surgery
Time frame: 30 Days post-surgery
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 14 Days Post-Surgery
Time frame: 14 Days post-surgery
Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 3 Months Post-Surgery
Time frame: 3 months post-surgery
Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 30 Days Post-Surgery
Time frame: 30 Days post-surgery
Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 14 Days Post-Surgery
Time frame: 14 Days post-surgery
Operative Time
Time frame: Intra-operative
Length of Hospital Stay (LOS)
Time frame: Admission to the hospital to discharge from the hospital (check out time), up to an approximate of one week
Conversion to Open
Time frame: Intra-operative
Number of Complications
Time frame: Intra-operative through the 3 month follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Intuitive Surgical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Scores from Baseline to 14 Days (time frame: 14 days post-surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.